Indivior Trading Update Reveals Hurdles Suboxone ANDA Filers Are Facing

Dr Reddy’s Laboratories is agonizingly close to resuming market activities for its generic Suboxone sublingual film product, but recently saw its case to have a mandate confirming the dismissal of a preliminary injunction turned down. In a market update, Suboxone manufacturer Indivior has outlined its plans to combat the imminent threat.

Arm wrestle
ANDA filers are attempting to wrestle for Suboxone film market share • Source: Shutterstock

Dr Reddy’s Laboratories, or any other Suboxone (buprenorphine/naloxone) sublingual film abbreviated new drug application (ANDA) filer, will face immediate competition from brand manufacturer Indivior’s authorized generic upon market entry of their ANDA product, the originator has confirmed as part of a trading update.

Indivior has also doubled down on plans to file by 20 December a petition for a rehearing by the original panel of US Court of Appeals judges of their 20 November decision vacating a preliminary injunction against Reddy’s

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